תפקידי ה-QP באירופה ובישראל

Roles, Responsibilities & Activities of the QP in Europe and in Israel
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 13306
שפת הקורס: אנגלית
על הקורס
עמדת משרד הבריאות לגבי שאלות שעלו ביום העיון –
תשובות לשאלות מהקהל מאת רחל שימונוביץ | מפקחת ארצית, תנאי יצור נאותים, משרד הבריאות

It is a legal requirement within the European Union, that only a Qualified Person (QP) releases medicinal product to the market. Article 48 of 2001/83/EC requires that ‘Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization has permanently and continuously at his disposal the services of at least one qualified person [QP], in accordance with the conditions laid down in Article 49, responsible in particular for carrying out the duties specified in Article 51.’In addition, EU law requires a QP in other areas such as Clinical Trials and Herbal Medicines.  The new directive on Falsification of Medicines will be discussed as to its impact on the QP and the supply chain, and the new draft on the QP and batch certification will also be reviewed.

The purpose of this course is to discuss and review the role, responsibilities and activities of a QP over the product life cycle including the supply chain.
 

קהל היעד
  • QP’s of manufacturing & Importing Companies
  • Regulators and Medicines inspectors
  • Regulatory Affairs Professionals
  • Quality Assurance Managers
  • Quality Control personnel
תפקידי ה-QP באירופה ובישראל
התועלת שתופק

Participants who attend this course will get an insight into what a Qualified Person is required to do in order to disposition drug products within the EU in compliance with EU directives and national regulations. The course will cover all aspects of the QP roles and responsibilities and the participants will be able to apply this knowledge in some workshop. In addition the participants will learn what key skills are required to be able to carry out the role of the QP and understand what the regulatory authorities expect from the QP, and how much discretion a QP can apply to decision making and still be compliant with the GMPs. > the holder of the manufacturing authorization has permanently and continuously at his disposal the services of at least one qualified person [QP], in accordance with the conditions laid down in Article 49, responsible in particular for carrying out the duties specified in Article 51.’In addition, EU law requires a QP in other areas such as Clinical Trials and Herbal Medicines.  The new directive on Falsification of Medicines will be discussed as to its impact on the QP and the supply chain, and the new draft on the QP and batch certification will also be reviewed.

The purpose of this course is to discuss and review the role, responsibilities and activities of a QP over the product life cycle including the supply chain

השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • EU GMPs and the QP
    • Background and Updated European Regulations.
    • Falsified Medicines Directive
    • MRAs and ACAAs
  • Roles and Responsibilities of the QP
    • The QP and Annex 16
    • QP Code of Conduct
    • QP Discretion
    • QP Declaration
  • The QP and Qualification and Validation
    • Why does the QP need to know?
    • What is the QPs involvement?
    • Good Quality Control Laboratory Practices and OOS/OOT
  • The QP and the Supply Chain
    • Suppliers and Service providers
    • GMP and excipients
    • API and Drug Product Quality
    • Good Distribution Practices (GDP)
    • Falsified Medicines Directive
    • Technical agreements
    • Product Quality Reviews
  • Batch Certification (Draft guidelines for review)
    • What is required to be able to make good decisions?
  • The role of the QP in Regulatory Inspections
    • What are the “Hot “topics to be aware of?
  • What skills does a QP require?
    • Academic and practical skills
    • Influencing skills
    • Statistics
    • Risk Management
    • Integrity
    • Patience
    • Decision making skills
אודות המרצה

Dr. Christopher Burgess

Dr. Christopher Burgess has over 35 years experience in senior management and consulting positions within the pharmaceutical, biopharmaceutical and medical device industries. He has acted as a Qualified Person within the EU for more than 25 years and is an Advisory Board member for the European Qualified Person Association.
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Mr Richard Bonner

Richard Bonner is a Biochemistry graduate and is currently located in the UK and works as a consultant to the pharmaceutical industry. He is now the Director of Regulatory Affairs for the European Compliance Academy (ECA) interfacing with international regulatory agencies around the world.
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